Germany Cannabis License Guidelines

Licensing and Enforcement Criteria

The Federal Institute for Drugs and Medical Devices (BfArM) is an independent federal authority within the Federal Ministry of Health.

On April 1, 2024, the Cannabis Act came into effect, removing the regulations of cannabis from the Narcotics Act.  Recent risk assessments have determined that cannabis in no longer a narcotic under German Law.  Cannabis for medical purposes and cannabis for medical-scientific purposes will in future be regulated in the Medical Cannabis Law Article 1 of the Cannabis Act contains the law on the handling of consumer cannabis, Article 2 contains the law on the supply of cannabis for medical and medical-scientific purposes. Other articles of the law amend, among other things, the Narcotics Act, the Narcotics Prescription Ordinance and the Narcotics Foreign Trade Ordinance.

A permit or contract from the Federal Institute for Cannabis Medicines and Medical Devices is required for anyone wanting to grow, produce, trade, import, export, distribute, or package cannabis for medical-scientific, or commercial legal cannabis sales.

Cultivation and distribution is not carried out by the Federal Institute for Drugs and Medical Devices but is instead performed by companies that are selected in a Europe wide search that is processed and commissioned by the cannabis agency.

There are no dispensaries or ways of purchasing recreational cannabis legally in Germany.  You may grow your own cannabis with up to three plants at home.  Persons can join a cannabis club to receive cannabis, the clubs will be allowed to grow its own cannabis come July 1, 2024.

Germany Cannabis Law & Compliance

Several laws and ordinances regulate the Germany cannabis industry, as well as the many different steps in the supply chain. These laws range over dispositions for cultivators, manufacturers, distributors and retail dispensaries. The most recent news can be found on these websites:

FAQs

When do I need a permit according to Section 4 of the Medical Cannabis Law Act to participate in the sale of cannabis for medical or medical-scientific purposes?

Anyone who wants to grow, produce, trade in, import, export, sell, sell, otherwise place on the market, procure or acquire cannabis for medical purposes or cannabis for medical-scientific purposes requires a permit in accordance with Section 4 of the Medical Cannabis Law Act.  The responsible body for granting permission is the Federal Institute for Drugs and Medical Devices.

The Federal Institute for Drugs and Medical Devices can grant permission for the use of cannabis for medical and scientific purposes for scientific purposes or, only in exceptional cases, for other purposes in the public interest.

What fees apply for an application according to the Medical Cannabis Act?

The fees for issuing permits and authorizations are based on the provisions of Section 1 of the Federal Fees Act in conjunction with Section 15 of the appendix to Section 2 Paragraph 1 of the Special Fees Ordinance.

Can cannabis be stored together with narcotics for medical or medical-scientific purposes?

The storage of cannabis for medical or medical-scientific purposes in the narcotics room or narcotics safe is permitted provided that it is carried out separately (e.g. in a separate shelf area) and with appropriate labeling, even if narcotics are to be stored separately in accordance with Section 15 of the Narcotics Act.

How can a permit to grow medical cannabis be obtained?

To obtain permission to grow cannabis for medical and medical-scientific purposes, an application must be submitted to the Cannabis Agency.
The documents must be submitted in accordance with Section 7 of the Medical Cannabis Act as well as a valid manufacturing permit/a valid Good Manufacturing Practices certificate from the responsible authority.

What are the tasks of the cannabis agency?

The tasks are based on the existing tasks from the Cannabis Act of 2017 and the Supply of Cannabis for Medical and Medical-Scientific Purposes.  Among other things, the agency is responsible for issuing permits for the cultivation of cannabis for medical and medical-scientific purposes. For permission to grow for medicinal purposes, the requirements for the pharmaceutical quality of herbal medicines must be met. These are to follow the quality-determining process steps of cultivation, harvesting, trimming, drying and storage.

The pharmaceutical quality of the cannabis flowers is determined by the requirements of “Good Agricultural and Collection Practice (GACP), the requirements of the “Good Manufacturing Practice” (GMP) and the requirements of the monographs ensured. This ensures the availability of cannabis flowers in reproducible quality and in accordance with pharmaceutical law requirements for patients.

Which substances and preparations are subject to the regulations according to the Medical Cannabis Act?

In addition to cannabis flowers and cannabis extracts, the legal change also affects dronabinol, Delta9-tetrahydrocannabinol and preparations made from these substances (see Section 2 Medical Cannabis Act).  Accordingly, the regulations under the Medical Cannabis Act also apply to the finished medicinal product Sativex.

However, medicines with the active ingredient nabilone (Canemes) are still subject to the regulations under the Narcotics Act.

Germany Cannabis License Types

Germany is currently working mostly with contracts instead of a license system to a limited number of companies.

Cultivation – Demecan. Aurora Production, and Aphria RX are the three companies that were awarded contracts to grow cannabis for medical purposes in Germany as part of a European selection process by the Federal Institute for Drugs and Medical Devices.  Each company specializes in cultivation and processing of medical cannabis in Germany.

Distribution — In 2020, the Federal Institute for Drugs and Medical Devices awarded Cansativa the contract to provide logistics and wholesale services for cannabis flowers grown in Germany for medicinal purposes.  Cansativa GmbH has its own distribution and fulfillment center and acts as a manufacturer, importer and distributor of cannabis for medical purposes in Germany.

Pharmacy — Medicinal cannabis can only be purchased through pharmacies in Germany the same way any other prescription is filled when prescribed a medicine by a doctor.

Cannabis Clubs – Cannabis clubs are non-profit organization that must have permission from the government to operate.  July 1, 2024 cannabis clubs may begin growing cannabis flower for sale within the club.

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